Autoinjector & Pen Injector Supply for Europe
Europe is the strategic certificate in our market map: a CE mark under MDR (EU 2017/745) takes 12–24 months — clinical evaluation, human-factors documentation and a notified-body slot — but once held, it anchors credibility in every emerging market that references European evidence. It is a program to schedule deliberately, not to improvise.
| Element | What it involves | Planning note |
|---|---|---|
| Classification | CE MDR IIb / III for autoinjector class devices | Confirmed per device with your notified body |
| Clinical evaluation | Literature route plus device-specific evidence | Device documentation feeds it — see compatibility |
| Human factors | Use-related risk analysis and validation studies | Device-side behaviour specs supplied by us |
| Notified body | Audit and certificate issue | Slots are tight — engage 12–18 months ahead |
| EUDAMED | Registration database | Mandatory since 2026-05-28 |
Therapy fit and platform match
European demand concentrates on biologics, GLP-1 maintenance, emergency use and chronic self-injection — mapped across the WH-DF prefilled platform, WH-DG adjustable configurations, UrgoPen and the WH-RG reusable pen. Device-side documentation — ISO 11608 reports, ISO 10993-1 biocompatibility data, ISO 13485 certificate with finished-device scope text — is prepared to feed your CE technical file.
How to verify us
Ask for the compliance scope in writing — which standards apply, who holds each certificate, and the MDSAP dates (effective 2026-02-12, expiry 2029-02-11) — then confirm the notified-body schedule with your own RA team: the calendar, not the brochure, is the critical path. Certificate copies themselves are released with the order documentation.
This page does not cover
Notified-body contracts, clinical evaluation report writing and EU authorized-representative appointments are your RA team's and AR's work. Device documentation is ours.
Planning a program for this region?
Send your container format, therapy area and target country — we return the platform match, the regional documentation set and written pricing within one working day.
Start the inquiry